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Stat Methods Med Res. 2009 Feb;18(1):7-26. doi: 10.1177/0962280208092342. Epub 2008 Jun 18.

The methodology of self-controlled case series studies.

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Department of Mathematics and Statistics, The Open University, Milton Keynes, MK7 6AA, UK.


The self-controlled case series method is increasingly being used in pharmacoepidemiology, particularly in vaccine safety studies. This method is typically used to evaluate the association between a transient exposure and an acute event, using only cases. We present both parametric and semiparametric models using a motivating example on MMR vaccine and bleeding disorders. We briefly describe approaches for interferent events and a sequential version of the method for prospective surveillance of drug safety. The efficiency of the self-controlled case series method is compared to the that of cohort and case control studies. Some further extensions, to long or indefinite exposures and to bivariate counts, are described.

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